FDA.reportPublic FDA data

510(k) K133537

Device
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
Applicant
EPS BIO TECHNOLOGY CORP.
510(k) number
K133537
Product code
LFR  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-28
Date received
2013-11-18
Regulation
862.1345
Classification name
Glucose Dehydrogenase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Cynthia Hung
Address
# 8 R&D Rd.Iii, Hsinchu Science Park Hsinchu TW 30077 30077

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories2015-09-17
K142089ACCU-CHEK AVIVA EXPERT SYSTEMRoche Diagnostics Corporation2014-12-17
K131727CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEMCeragem Medisys, Inc.2014-02-28
K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.2013-10-11
K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical Corporation2013-04-04
K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.2013-02-14
K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical Corporation2012-12-20
K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.2012-11-09
K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-09-19
K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.2012-07-27
K121190CONTOUR NEXT BLOOD GLUCOSE METERBayer Healthcare, LLC2012-07-26
K120042TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-05-22
K121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.2012-05-18
K113768U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation2012-04-12
K110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)Bayer Healthcare, LLC2012-03-28

Legacy Summary#

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FDA Review#

Decision Summary